Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Leicester
About this trial
The study aims to examine the feasibility of a remote exercise program in women recovering from spontaneous coronary artery dissection (SCAD) events (heart attacks). Heart attacks caused by SCAD are different to the traditional heart attacks. In SCAD a tear happens within the blood vessels causing partial or full blockage. The population affected by SCAD is hugely different to the population affected by other 'traditional' heart attacks; as SCAD mainly happens in otherwise healthy women. From historical cases, SCAD has been associated with strenuous exercise, however, medical research did not find a link. The recovery after SCAD is also very different from other 'traditional' heart attacks. Cardiac rehab programmes are designed for an older population therefore they may not be suitable for a younger predominantly female population. This study will examine if a remote-exercise programme is achievable in people after a SCAD event.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Aged ≥18 years.
Diagnosed with angiographically confirmed SCAD and referred to the Leicester SCAD clinic.
Ejection fraction >45%.
Disqualifiers
No SCAD diagnosis.
Unable to travel to Leicester Hospital for their SCAD clinic appointment.
Unable to give informed consent.
No smart phone or internet access
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise training
Behavioral12 week exercise intervention + cardiopulmonary exercise test (CPET) + wearable activity monitor
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Exercise InterventionExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
Rate of successful recruitment
Time frame
From initial patient identification until the patient consents to be part of the study. This may take up to 14 days (from initial approach until full informed consent is obtained).2
Adherence
Rate of successful adherence
Time frame
At week 8 (56 days) of the intervention.3
Acceptability
Acceptability of the intervention assessed via qualitative interviews which will be then transcribed verbatim. Acceptability will be assessed via thematic analysis of semi-structured interviews. Once patients completed T3 (+/- 7 days), they will be invited to take part in semi-structured interviews.
Time frame
At 24 (168 days) of the intervention (this is follow up time point three (T3)).4
Signal of efficacy: Changes in exercise duration
Changes in exercise duration expressed in time (hours: minutes) measured by the activity monitor(s) over the study period.
Time frame
At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).Secondary outcomes
1
Self-efficacy: Self-efficacy questionnaire
Self-reported self-efficacy levels via the self-efficacy questionnaire. This questionnaire uses a 10-item Likert scale, where minimum score is 1 (not at all true) and the maximum score is 4 (exactly true). The overall score range therefore is 10-40 where higher scores indicate better self-efficacy.
Time frame
At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).2
Chest pain: Seattle Angina Questionnaire-7
Self-reported chest pain via the Seattle Angina Questionnaire-7 (SAQ-7) uses a four week recall period therefore the scores can be translated into frequency of angina symptoms 0-30=daily angina, 31-60=weekly angina, 61-99=monthly angina and 100=no angina). The summary score range from 0 to 100 with higher scores indicating less angina and overall better quality of life.
Time frame
At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).3
Wellbeing: Warwick Edinburgh Mental Wellbeing Scale
Self-reported wellbeing via the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). This is a 14-item Likert scale questionnaire with 5 response categories (1=None of the time to 5=All of the time). The total score can range from 14-70, where higher scores indicate better wellbeing.
Time frame
At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).4
Anxiety: Generalised Anxiety Disorder
Self-reported general anxiety levels will be assessed via the Generalised Anxiety Disorder questionnaire (GAD-7). The GAD-7 scores each item in a Likert-scale fashion, where 'Not at all' is scored as '0', 'Several days in scored as '1' , 'More than half the days' is scored as '2' and 'Nearly every day' is scored as '3'. Higher values indicate more severe anxiety (where maximum score is 21). The data then can be categorised into the following: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety.
Time frame
At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).Sponsors and contacts
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University of Leicester
Lead sponsor
University Hospitals, Leicester
Collaborator
Edinburgh Napier University
Collaborator
Source ClinicalTrials.gov